drugset / Trial / NCT02769689

Methylprednisolone During the Switch Between Natalizumab and Fingolimod

NCT02769689

Phase 4 Unknown 56 enrolled University Hospital, Clermont-Ferrand
RandomizedParallel-groupDouble-blindTreatment

Summary

Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT. The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).

Timeline

Start
2019-06-12
Primary completion
2024-06-20
Completion
2024-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 1 g Oral
Background Fingolimod Small molecule
Background natalizumab Monoclonal antibody

Indications